Humans have long dealt with the pain, aggravation and loss of productivity arising from spinal injuries, particularly those to the lower back. It is not without good reason that the phrase, "Oh, my aching back|" is a common part of our everyday lexicon. The relative ease with which injuries to the spine and supporting musculature are incurred, as well as the debilitating effects of even slight injuries, merely adds to the overall severity of the problem of dealing with spinal injuries. Further aggravating the situation is that the most frequently prescribed regimen of treatment for spine-related injuries, short of surgical intervention, is the cessation or severe curtailment of almost all physical activities likely to give rise to torsional or compressional stresses to the affected regions of the spinal cord. In practical terms, due to the pervading effect of the spinal anatomy on all but the most sedentary and isolated of physical activities, almost complete immobility must be imposed to insure providing an injured spinal area sufficient opportunity to heal. In this context, the term "injury" relates not only to actual compression and torsional injuries to the various anatomical structures of the spinal cord and related neurophysiology, but also to general musculature strains of the large muscle groups interacting with various anatomical regions of the spinal cord.
The human spinal column is a major component of the skeletal system of thirty-three bones comprising seven cervical, twelve thoracic, and five lumbar vertebrae, with the latter merging endwardly into the five fused sacral and the four fused coccyx vertebrae. The twenty-four individual vertebrae have various bony projections with one projection, directed outward from the back of the spine, known as the spinous process. The individual vertebrae are connected and supported by various cartilages, muscles and ligaments which allow flexibility for bending and twisting of the torso. Between each vertebra is an intervertebral disc which functions to cushion and separate each vertebra, helping to prevent compression of the peripheral spinal nerves branching off from the spinal cord and housed within the spinal column. When subject to stresses, the interior structure of the disc can degenerate and/or rupture leading to a displacement of the intra-disc cushioning material and a resulting bulging of the outer disc surface. This bulging can impinge on nerve structures causing inflammation and aggravation of the neurological anatomy involved. Such neurological involvement is invariably accompanied by pain, loss of muscle strength decrease range of motion of the spine and possibly neurological involvement. In some cases, the outer surface of the disc can rupture completely leading to an extrusion of the viscous intra-disc material, a condition which can generally require invasive therapy.
Loss of normal spinal contour can also result in pain, in loss of motion, and neuro involvement.
A significant proportion of back pain experienced by the general public occurs in the lower portion of the back generally referred to as the lumbar region, or spinal segments L-1 through L-5. In those instances where pain is the result of neuro impingement, the pressure exerted against the nerves may be reduced by re-establishing normal contour of vertebrae of this region, resulting in reduction or elimination of pain. In a similar fashion, a proportion of spinal pain affecting the cervical region, or spinal segments C-1 through C-7, may be alleviated through reduction of neuro impingement at this level. A clinical approach to reduce this neuro impingement re-establish contour may involve use of traction. Traction has been demonstrated to be therapeutically effective in promoting healing of the affected anatomy with accompanying reduction of symptoms.
Back injuries are a very costly health problem for industry, as measured in terms of lost productivity. Some estimates place the total cost of back injuries to industry in the United States at approximately one hundred billion dollars per year. It is estimated that each year nearly half a million workers are permanently sidelined by back injuries. Lower back pain and other back injuries account for nearly forty percent of all work days missed, resulting in over 93 million lost work days per year. Many lower back injuries and low back pain result from improper lifting mechanics and technique. Thus, many of these injuries that occur could be prevented by proper lifting techniques; however, even with training in proper techniques, many workers fail to use such techniques and become injured.
The lumbar spine can be injured in many ways--two of which are namely, compression or torsion injuries. If the former occurs, a common result is damage to the vertebral endplate. Treatment option include: rest and physical therapy, medications and avoidance of physical activity likely to place excess stress on the spinal column. Surgery is rarely required, as is typical of the vast majority of day-to-day back injuries.
If torsion or twisting occurs, the common result is damage to the intervertebral disc. In some cases, the nucleus of an injured disc may rupture the annulus of the disc and protrude therethrough. Such a protrusion, or "slipped disc", can pinch the spinal nerves causing LBP and/or leg pain, muscle weakness and rarely paresis or paralysis. Corrective surgery to remove the protured disc material may be required. A series of minor torsional injuries may result in a weakened disc, which may be susceptible to more serious injury. Twisting toward an injured side may aggravate the injury and interfere with the healing process.
Because the human spine is the essential load bearing component in the human skeleton, an injury to any region of the spine generally causes some discomfort, immobility and/or pain. After an injury has occurred, it is important that the spine be given an opportunity to heal. Spinal motion around the injury should be avoided. If inadequate healing occurs, an injury may become chronic in nature, causing ongoing pain and discomfort to the affected individual. Because the spine is in constant use, it is continuously subjected to stresses which may interfere with the healing process. In some cases, bed rest, and other non-surgical measures may be adequate to allow an injury to heal fully.
Due to the frequency of spinal injuries, and the economic impact on the productivity and efficiency of both industrial workers and the general populace that result from such conditions, considerable attention has been directed toward the development of devices designed to address the problems associated with back and neck pain of varying etiologies. These devices can be characterized accordingly: First of all, there are many devices designed to prevent the occurrence of lower back injuries such as support belts and braces for workers engaged in repetitive lifting activities, or for the general populace during occasional lifting or athletic endeavors. Secondly, there are devices designed to be worn during everyday activities by individuals already exhibiting lumbar or cervical spinal injury symptoms. These devices can be similar in design to the preventative devices, allow the wearer to engage in activities while, in theory, still removing sufficient stress from the affected region of the spine to permit healing of the injury. Lastly, there is a group of devices designed to provide active therapeutic benefit in a clinical setting. Mechanical and/or gravitational traction devices for treating either the cervical or lumbar regions of the spine are exemplary of such devices.
With respect to the first class of devices mentioned above, it has been found that support to the lower back of workers through the use of belts, braces or wraps can reduce the occurrence of back injuries, perhaps because such devices provide support, and encourage workers to use better lifting technique. Such belts, braces or wraps appear to provide support by compressing the tissue around the spine so as to stabilize the lumbar region and prevent substantial lateral motion of the lumbar vertebrae relative to one another which, if left unconstrained, could otherwise occur and cause painful injury. Such devices are of little benefit, for a variety of practical reasons, for prevention of injuries to the cervical spine.
Many support belts used in the past were widened belts which were tightened to provide pressure, and did not promote correct extension of the spine. This type of device is exemplified by the U.S. Pat. No. 4,685,668, issued on a weight lifting belt to T. L. Newlin, Jr. on Aug. 11, 1987. These belts were relatively rigid and too much pressure could be applied directly on the spinous processes of the vertebrae, which was especially evident when the wearer bent over, resulting in pain along the spine. Wearing this type of belt for an extended period of time also tended to constrict blood flow and cause skin irritation.
Many of these prior art belts, braces or wraps have also been designed specifically to reinforce proper lifting techniques. When lifting heavy objects, it is preferable to use the legs as much as possible to perform the lift, thus relieving strain from the spine and muscles of the back. To insure that the legs are doing most of the lifting as opposed to the back, the lift should begin with the lifter in a squatting position with the back aligned within 45 degrees of vertical. However, individuals often lift items with the back aligned 45-90 degrees beyond vertical such that the back bears most of the load during lifting. Many braces incorporate features which make it uncomfortable for a wearer to bend their back more than 45 degrees from vertical, thereby mechanically constraining the wearer from exceeding a degree of alignment of the back associated with proper lifting technique.
Often these devices employ padded regions designed to come in contact with the lumbar region of the spine, providing additional support to that region. Specific examples of belts designed to place various pads against the lumbar region of the wearer's back are shown in U.S. Pat. No. 4,991,573 to Miller in which the principal inventive focus of the device is the specific design of the lumbar pad; U.S. Pat. No. 5,188,586 to Castel et al. which discloses a back brace designed to prevent injuries to the lower back and impose proper lifting technique on the wearer by constraining the range of motion during lifting; U.S. Pat. No. 4,768,499 to Kemp discloses a lifting belt with an unpadded lumbar panel, also designed to provide additional support to the abdominal region of the wearer during lifting; and U.S. Pat. No. 5,060,639 to Marcus which also discloses a back support providing additional support to the abdominal region of the wearer, including an embodiment suited for use by expectant mothers in the latter stages of pregnancy.
Numerous examples also exist of braces and belts which utilize a lumbar pad comprising fluid-filled compartments designed to conform to the unique contours of the wearer's back. For example, U.S. Pat. No. 4,622,957, issued Nov. 18, 1986 to Curlee, discloses a therapeutic corset adapted for the sacrum, lumbar and thoracic regions of the body. The corset includes a padded bladder provided with a duct for introducing fluid. The inflated bladder is disposed next to the user for the purpose of "filling" the unique contours of the sacro-lumbar region of the spine by providing a pressure for comfort to specific areas while controlling the overall stability of the thoracic spinal region. U.S. Pat. No. 4,552,135, issued Nov. 12, 1985 to Racz, et al., also shows a "Lumbar Belt" with a relatively large rear belt section superimposed over the small of the back, and an air-filled chamber disposed between the small of the back and the belt. U.S. Pat. No. 5,111,807 to Spahn et al. also discloses a back belt with a pressurizable air chamber in the lumbar region pad, along with unique connector means designed to couple the diverse materials of construction of the belt in a manner superior to that of conventional sewing. However, all of these devices, although designed primarily to constrain the range of motion of the wearer to prevent injury, also result in a compression of the lumbar area which can have little or no therapeutic value and, in some instances, can actually result in an increase in the likelihood of the wearer to sustain a compressive-type injury.
In conformance with the second category of back devices described above, braces and belts of various designs are used to support the lumbar region of the spine after it has been injured. An example of such a device is disclosed in U.S. Pat. No. 4,691,696 to de los Godos, which comprises a belt with one or more bracing structures designed to prevent torsional rotation of the wearer's back in the direction of an existing injury, thereby relieving stress from the injured area and providing an opportunity for the injury to heal.
Additional support braces exist in the prior art, such as that disclosed in U.S. Pat. No. 5,062,414 to Grim, which utilizes one or more fluid-filled chambers in the lumbar region of the belt, optionally in conjunction with electrically heated resistive elements designed to warm the injured area. Another example of a brace comprising fluid-filled bladders in a lumbar pad, along with electrically heated resistive elements, is disclosed in U.S. Pat. No. 4,702,235 to Hong. The Sports Plus II Belt, as shown in the AliMed catalog of 1995, on page S108, utilizes a plurality of vertically-oriented air-filled chambers that are distributed within the belt and extend beyond the lumbar region alone. However, these chambers are capable of expansion only in a radial direction and, thus, can serve only to tighten the belt circumferentially around the wearer's waist. Moreover, the Sports Plus II Belt has no horizontally disposed support members capable of transmitting vertically directed forces for relieving gravitational stresses on the lumbar region of the spine or creating a traction-like effect.
Additionally, there are several well known braces of the wrap-around corset type. Such corset braces wrap around the trunk of the body in the region of the lumbar spine. Such braces, however, are intended to reduce the compressive stress in the lumbar spine or to totally immobilize it. They are thus of limited value in the treatment of torsional or twisting injuries. In addition, they may be uncomfortable and difficult to fit to larger persons. Moreover, the highly constraining corset design imparts almost complete immobility to the torso of the wearer and is, therefore, ill-suited for use while pursuing day-to-day activities. Rigidly reinforced or rigid frame back braces are also well known. Such braces, however, also completely immobilize the entire spine. A patient using such a brace is rendered essentially disabled because he cannot move his spine in any way.
According to the third category of back devices described above, there are a number of braces and other such devices which are designed to provide active therapeutic benefit and to promote healing of the injured area. Generally, these devices can range from full-scale clinical appliances in the form of tables, chairs or other like structures, to belts and slings designed to be used in conjunction with large appliances. In theory, these devices function by suspending the weight of the affected patient in a manner that almost totally removes all gravitational stresses from the affected area of the spine. Thus, in contrast to the second category of devices described above, traction devices do far more than merely constrain the movement of the affected region of the body. Generally, they are part of an aggressive, non-surgical or post-surgical regimen designed to keep the spine free from torsional and compressive forces, thus allowing the injured area to heal as rapidly and effectively as possible. The major drawback of most tractional therapies is that, due to the complexity of the apparatus and the need for substantial intervention by an appropriately trained health care professional to assure proper therapeutic use and optimal benefit, they are suited only for use in controlled, clinical settings. The time that a patient spends in a normal traction device must be dedicated time during which the patient is incapable of participating in any other activities.
An example of an orthopedic lumbar traction brace used in conjunction with traction appliances is disclosed in U.S. Pat. No. 4,269,179 to Burton et al. The brace of the Burton et al. patent is designed to be attached to the lower rib cage of the patient. The patient, while wearing the device, is suspended through the supporting straps of the device from a multiple-position table which can be adjusted to an optimal angle to achieve a desired amount of gravity traction. Thus, the weight of the patient's upper body is suspended from the brace about the patient's lower rib area and the lumbar region of the spine is relieved of the normal gravitational stresses the patient's body weight would impose even when completely motionless in a standing or sitting position. In conformity with the general comments above, a patient using the brace and traction device disclosed in the Burton et al. patent would be precluded from engaging in physical activity of almost any kind.
U.S. Pat. No. 4,991,572 to Chases discloses another type of lumbar traction harness designed in theory to use the principles of gravity traction to relieve stresses from the lumbar spinal region, permitting efficient healing of the affected area. Unlike the device of the Burton et al. patent, the Chases device utilizes an air-inflated bladder to increase the comfort of a patient using the device for traction therapy. This device is basically a traction sling which is adaptable to use in a variety of conformations and patient alignments. This variety of configurations is best illustrated by reference to FIGS. 6-11 of the Chases reference. As disclosed in the reference, the principal advantage of this device is its flexibility of use, being adaptable to a number of patient orientations, unlike the majority of prior art traction table devices, whether mechanical or gravitational, such as those used in conjunction with the device of the Burton et al. patent. However, as is universally true of this type of therapeutic traction device, the patient undergoing therapy must dedicate the time to participate in the therapy and cannot pursue any normal day-to-day activities, whether or not employment-related, during therapy.
Similarly, treatment of cervical injuries or disorders often requires cervical traction for treating trauma to the muscles and ligaments of the neck and the cervical and upper thoracic vertebrae and associated spinal nerves. By applying cervical traction, a "cervical separation" is produced which alleviates pain caused by compression on the nerves, while allowing more blood flow to the affected tissue that speeds the healing process.
Normally, in the early stages of applying traction, cervical traction forces are most easily controlled when the patient is confined to a hospital bed where more complex and expensive traction equipment is carefully controlled by medical professionals. When the patient has reached a point in the healing process where such a level of clinical treatment is not needed, other controlled traction devices may be prescribed and used by the patient.
One such home use traction device is an "over-door" cervical traction system in which traction forces are applied to a head halter or harness placed under the chin and occipital lobe areas. (See Flaghouse Rehab, Inc. Catalog, 1933, p. 64.) The harness is connected to a hanger that attaches to a door and holds a water-filled weight bag that applies a controlled amount of upward traction force on the harness by gravity while the patient sits next to the door that supports the hanger and weight bag. This traction system applies traction forces by the weight bag pulling the harness upwardly from below the chin region and the base of the skull. The amount of water contained in a weight bag controls the amount of traction force. Although this system is useful, it requires a patient to sit in one place for long periods of time.
Another prior art patient-controlled cervical traction device is available under the name Pronex from Glacier Cross, Inc. This device includes a U-shaped block that fits behind the patient's neck and rests on the patient's shoulders. An air-inflatable bellows in the middle of the block applies lateral lifting forces upwardly to pillows on opposite sides of the patient's neck. This device requires the patient to be immobilized in a horizontal position while traction is applied. The traction force is not uniform around the entire neck region and the bellows, being located at the middle of the device, can apply undesired inward pressure to the middle of the patient's neck and windpipe. Such a device is similar in function and design to that disclosed in U.S. Pat. No. 5,441,479 to Chitwood, issued Aug. 15, 1995.
U.S. Pat. No. 5,403,266 to Bragg et al., issued Apr. 4, 1995, discloses a cervical traction collar that can be used by a patient to apply a controlled amount of traction-type force to the cervical region. The device of this patent uses a circumferentially-distributed air-inflated bladder disposed at the bottom edge of a rigid central brace portion similar to conventional rigid cervical braces (see, for example, U.S. Pat. No. 5,230,698 to Garth, issued Jul. 27, 1993). As the bladder inflates, the rigid brace portion is forced upward to towards the wearer's chin, exerting tractional forces on the cervical spinal region. However, significant disadvantages remain for a design of this sort in that the inflation of the circumferentially-distributed bladder is inevitably accompanied by a radial constriction of the wearer's lower neck region. The rigid neck brace portion of the device can also be a source of some discomfort to the wearer, thus diminishing the likelihood that the device will be worn for a sufficiently long period of time to optimize its clinical benefits.
Thus, each of the categories of spinal braces and devices described above, although useful, exhibit considerable drawbacks and inefficiencies. The first category of devices, those designed to prevent injury and/or to encourage proper lifting technique, are hampered by a limited efficacy. Furthermore, such devices generally act by compressing the lumbar region in a plurality of dimensions and, aside from restricting motion within a safe range, can possibly lead to an increased likelihood of certain types of back injuries. The second category of devices, those designed to protect an injured wearer while the wearer engages in physical activities, offers not much more protection than those devices designed to decrease the likelihood of initial injury. These latter devices function merely by restricting motion and/or by providing direct support to the lumbar or cervical regions. Certain devices are also capable of providing heat to the affected area as well. However, both of these initial categories of devices, although they permit the wearer some range of physical activity, can do no more to treat existing injuries than to minimize the likelihood of re-injuring an affected area, or aggravating an existing injury. They are incapable of providing active therapeutic benefits leading to enhanced healing of injuries of the various spinal regions. Despite whatever other utility these devices may display, the inability to actively promote healing is a significant drawback to these types of devices.
Back pain is common in normal pregnancy. More than 50% of all women experience some kind of back pain during pregnancy. Such pain can be classified into highback, lowback and posterior pelvic pain. Early studies have shown that for a successful treatment of back pain during pregnancy it is crucial to distinguish especially between low back pain (LBP) and posterior pelvic pain (PPP). At a glance these two conditions may share many characteristics in clinical status as well as in history, and therefore pregnant women with any type of back pain often have given the same kind of treatment or, more commonly, no treatment at all. Furthermore, some pregnant women suffer from both types of pain which complicates the situation. While LBP in pregnancy does not appear to differ substantially from the back pain well known in the general population, posterior pelvic pain is seldom found in men or among women who have never been pregnant and seems to be connected with the pregnancy hormones estrogen and relaxin.
To carry her pregnancy, the human female increases the lumbar curve, with a resultant disequilibrium of the vertical alignment of the body. There is a partial loss of abductor function of the gluteal muscles and wobbling. The hormone, relaxin, stretches all the lumbar and pelvic joints. This makes erect locomotion and even erect posture painful and tiring.
Erect posture is not only an unstable equilibrium, but a succession of unstable equilibrium's that manage to balance and correct each other. The result is a highly unstable equilibrium. In quadrupedal posture, it is the opposite; the center of gravity (CG) is low and the base of support is wide. In bipedal posture, it is the opposite; the CG is high and base support is narrow. This is main reason for instability of erect posture. How fragile and unstable erect posture is can be demonstrated in different ways. Humans takes the longest time to acquire perfect posture during infancy. It starts between 1 year and 18 months of age, but is not perfect until six to seven years of age.
Since erect posture is acquired and practiced before complete ossification, one can conclude that erect posture tremendously influences (in fact, determines) the anatomy of the human body and specifically the anatomy of the pelvis and spinal column during the time erect posture is being acquired.
In the study of orthopedic dysfunction of the human body one should never forget that for one billion years the body preceding humans was quadrupedal, the spinal column was horizontal, and the pelvis barely supported any structure. The whole orthostatics and orthodynamics of the mammalian body become altered when the truck rotated 90 degrees around the hip-joint area and the pelvis had to support the whole trunk.
Erect posture is not only a phylogenetic (genetic) inheritance, but also ontogenetic since the human infant starts out quadrupedal and only later switches to bipedalism. Quadrupedal ancestry is very well established in the human body and bipedal adaptation is very recent. The whole anatomy and physiology has had to readapt to a erect behavior, and this readaptation is not always perfect. The typical example to quote is the position of the heart within the chest. In quadrupedal posture, this organ peacefully rests on the sternum for a entire lifetime, while in and erect posture it floats in the middle of the chest with practically no strong anatomical support; all this predisposing the human heart to numerous heart conditions. The impression one gets from a review of the extinct forms that preceded Homo Sapiens is that present erect behavior is unstable and easily subjected to defects. There is hardly any organ of function in the human body that has not readapted to erect posture and locomotion.
Most current orthotic braces try to offer relief to back problems by the following; (1) Relieve Low Back Pain LBP, (2) Relieve Abdominal Muscle, (3) Reduce Leg Pain, (4) Stabilize the Pelvic Ring.
With respect to the product P.R.'s Mother-to-be, C.M.O. Inc., Barberton Ohio, the claim is made that the device prevents distortion of the lumbar curve, by transferring the weight of the abdomen. The abdomen exerts downward pressure on to the abdominal lift pad creating a greater pressure against the custom molded insert. This in turn is claimed to force the lordosis curve into its natural curve. Accordingly, it is reasoned that the greater the abdomen weight, the greater the support. The problem with the above device and those made similarly is that the device does not prevent distortion of the lumbar curve, but only transfer of the abdominal weight.
In 1854, Carpal Tunnel Syndrome was described as a complication of trauma. Today it is recognized as a extremely common entrapment syndrome.
The carpal tunnel area compresses or traps the median nerve inside the wrist. The median nerve is one of several nerves which allows a person to move the hand and fingers. Not much was known about Carpal Tunnel Syndrome by health care professionals until and extensive article on the subject was published by Dr. Phalen in the 1970. The carpal tunnel is surrounded by eight carpal bones and a ligament (flexor retinaculum). Flexor tendons and the median nerve pass through the tunnel. When the median nerve within the tunnel is compressed by edema (fluid retention) caused by swelling of tissue or damage, the resulting symptoms are termed as carpal tunnel syndrome (CTS).
As keyboard usage in the workplace has increased, CTS is becoming a much more common occurrence. In the case of worker compensation, CTS is becoming increasing claimed as being worked related. CTS most commonly affects women in mid-life, and often pregnant women have the symptoms (edema) that resolve postpartum. Patients often complain of frequent pain in the distal arm or wrists or into the thumb, index or middle fingers with a increased when the wrist is in motion. With the most common (95 percent) relating to the fact of awaking in the middle of the night with painful numbness in the hand. Up to 50 percent of patients have bilateral pain in both upper extremities, and often describe electrical sensations in the median area.
Nonsurgical therapy for carpal tunnel syndrome is indicated when (1) symptoms are less than one year, (2) muscle weakness or atrophy are not present, (3) deviations is not found on electromyographic needle examination and (4) only mild abnormality show up on nerve conduction studies. Nonsurgical therapy may include the following pharmaceuticals, bracing, and steroids injections.